Osteoporosis is a disease of bone weakness in the elderly and also part of the general aging process. It is symptomless in most cases. When symptoms present, they usually present as either deep bone pain due to micro-fracture or even gross fracture of the bone due to mild trauma. Orthopedically, OP is defined as a reduction of bone mass per unit volume. This means that the bone loses substance leading the bone to become weak and easily fractured by milder traumas.
The bone is a biphasic material composed of two main components: Calcium hydroxyapatite (ceramic) and collagen protein. Ceramic comprises about 50% of the bone structure and gives the bone its glass-like rigidity. Collagen protein (bundle) comprises about 28% of the bone structure and gives the bone some degree of resilience, absorbing shock from trauma and protecting the bone from fracture by lessening its intensity. The remaining 22% of bone is comprised of water.
Present medications for the treatment of OP include bisphosphonates, in combination with Vitamin D, calcitonin and/or calcium supplementation. These medications have many side effects including: gastro-intestinal upset, headaches, drowsiness, atrial fibrillation, osteonecrosis of the jaw, oesophageal cancer, and subtrochanteric fracture of the femur (11, 12). Furthermore, treatments are expensive and can require long term dosing from 6 months up to 2 years or more for effect. Moreover, these medications are not 100% effective in correcting OP and normalizing bone density. Furthermore, these medications show marked patient variability in response regardless of the degree of bone loss.
The most important drawback of current medications and treatment regimens is that medications use in current treatment regimens correct bone loss only by affecting bone eating cells (osteoclasts) resulting in a new bone which is evenly distributed or a uni-phasic bone regardless of the lines of the stress. However, recent research (1, 2) shows that the starting point of new bone synthesis is by deformation of collagen bundles inside the bone matrix and not in bone cells. The collagen bundles deform in response to mechanical stress and produce an electrical gradient difference which is capable of stimulating bone forming cells to synthesize new bone at the sites of stress. The formation of new bone by mechanical stress was discovered in 1892 and was defined as Wolff's law, (1) & (19) (20). However, the electrical gradient difference (16), discovered later in 1963, was still not clear. With the aid of electron microscopic studies in 2007, the piezo-electric theory became clear: the compression side of collagen bundles show negative charges and are capable of stimulating bone forming cells (8). On the other hand, positive charges, arising on the tension side, are capable of stimulation bone eating cells (8). Hence, there is a need for treatments targeting this mechanism and other phases of OP pathology.
There is a continuous need for new medications for treatment of osteoporosis which are more effective, cheaper and with fewer side effects. The object of this invention is a treatment of osteoporosis with all of the above advantages by targeting the underlying pathology of OP and stimulating bone formation where it is most needed, at the lines of stress.